Methods: Randomized, triple-masked, crossover trial to measure effects of Original Healing Salve on the TcPO2 in the skin of the lower extremity in people with type 2 diabetes without peripheral artery disease. Participants were assigned in random order to receive either the Original Healing Salve (test), or the salve base alone (control). After a 20 minute warm up cycle, the salve was applied and oximeter (Radiometer America, Inc.) readings were recorded from four sensors (two lower leg, and two foot) at 5 minute intervals for 30 minutes. The primary outcome was the difference in TcPO2 in the lower leg sensors between the test and control salves at 30 minutes after application by ANOVA. The secondary outcome was change in TcPO2 in the leg sensors from the application of the test salve by paired t-test. Exploratory analyses evaluated changes in TcPO2 at all time points and assessed for trends over time.

Results: Sixteen participants with type 2 diabetes were randomized, and completed the trial. The mean difference in TcPO2 at 30 minutes in the leg sensors combined = 0.39 +/- 8.54, p = 0.86. Within the test group, the mean change in TcPO2 at 30 minutes in the leg sensors = 3.70 +/- 6.62, p = 0.04. There were no significant differences between the test and control salves at any time point. Significant linear and cubic trends were measured in both treatment groups, suggesting increases in TcPO2 over time.

Conclusion: The Original Healing Salve increased TcPO2 after 30 minutes in people with type 2 diabetes, however the contribution of the herbal and homeopathic ingredients remain unclear.